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Eliminating Surgery After Systemic Therapy in Treating Patients With HER2 Positive or Triple Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT02945579
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : December 17, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This clinical trial studies eliminating surgery and how well radiation therapy after systemic therapy works in treating patients with HER2 positive or triple negative breast cancer when image-guided biopsy shows no residual cancer. Patients then receive standard breast radiotherapy.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Procedure: Breast Biopsy Radiation: Radiation Therapy Behavioral: Questionnaire Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the 6 months (mo), 1, 2, 3, and 5-year biopsy confirmed ipsilateral breast tumor recurrence rate (IBTR, invasive, and/or in situ) among patients who do not undergo surgery.

SECONDARY OBJECTIVES:

I. To determine the number (%) of patients where final biopsy reveals residual disease and quantify the residual disease (residual cancer burden, RCB) determined by routine pathologic examination of surgery specimens.

II. To assess baseline, 6 months, 1, 3, and 5 years decisional comfort of clinical trial participation using the Decisional Regret Scale (DRS).

III. To determine patient-reported cosmetic outcome, breast pain, and functional status using the Breast Cancer Treatment Outcomes Scale (BCTOS) at baseline, 6 months, 1, 3, and 5 years.

IV. To determine the 6 mo, 1, 2, 3, and 5-year incidence of ipsilateral breast and nodal recommendation and performance of biopsy based on breast imaging follow-up.

V. Correlate "liquid biopsy" analyses (after neoadjuvant systemic therapy [NST], 6 months and one year postradiotherapy or surgery) among protocol participants with pathologic complete response (pCR), utilizing circulating tumor cells (CTCs) and circulating tumor-deoxyribonucleic acid (DNA) (ctDNA).

VI. Among patients who decide to proceed with routine surgery, record the results of final biopsy compared with routine pathologic examination of surgery specimens.

VII. To determine patient-reported quality of life using the Functional Assessment of Cancer Therapy-Breast version 4 (FACT B+4) instrument at baseline, 6 months, 1, 3, and 5 years after treatment.

OUTLINE:

Within 12 weeks of completing neoadjuvant systemic therapy, patients undergo whole breast irradiation over 15-25 fractions on consecutive days. Patients then undergo external beam radiation therapy (EBRT) boost over 7 fractions on consecutive days beginning the day following completion of whole breast irradiation.

After completion of study treatment, patients are followed up every 6 months for 5 years.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Trial for Eliminating Breast Cancer Surgery in Exceptional Responders With Neoadjuvant Systemic Therapy
Actual Study Start Date : January 20, 2017
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Breast Cancer Surveillance

Feasibility Phase to enroll 6 participants then Expansion Phase begins.

Image-guided biopsy of the breast performed after completing chemotherapy and before beginning radiation therapy.

Radiation therapy to the breast performed within 12 weeks after completion of chemotherapy.

Questionnaires completed at baseline and again at 6 months, 1, 3, and 5 years after post-chemotherapy biopsy.

Procedure: Breast Biopsy
Participant undergoes an image-guided biopsy of the breast to test for evidence of disease at any point after completing chemotherapy and before beginning radiation therapy.

Radiation: Radiation Therapy
Radiation therapy to the breast performed within 12 weeks after completion of chemotherapy. The dose amount and length of the radiation therapy period decided by treating physician.
Other Names:
  • XRT
  • External beam radiation therapy

Behavioral: Questionnaire
Questionnaires about quality of life and symptoms completed at baseline and again at 6 months, 1, 3, and 5 years after post-chemotherapy biopsy.
Other Name: Surveys




Primary Outcome Measures :
  1. Feasibility of Treatment Regimen [ Time Frame: 6 months after radiation therapy ]
    If none of the first 6 patients with pathologic complete response (pCR) are to experience an ipsilateral breast tumor recurrence (IBTR) during their first 6 months after they obtain a pCR, proposed treatment regimen is feasible.

  2. Ipsilateral Breast Tumor Recurrence-Free Survival (IBT-RFS) [ Time Frame: 5 years ]

    Ipsilateral breast tumor recurrence-free survival (IBT-RFS) defined as the time from confirmation of pCR to the time of ipsilateral breast tumor recurrence or death, whichever occurs first or the time of last contact.

    IBT-RFS monitored using the method of Thall et al.




Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed unicentric invasive breast cancer defined as radiologic clinical stage T1 or T2 (=< 5 cm), N0 or N1 (=< 4 abnormal axillary nodes on initial ultrasound), clinical stage M0
  • HER2 positive (immunohistochemistry [IHC] 3+ and or fluorescence in situ hybridization [FISH] amplified) or triple receptor negative (triple negative [TN], estrogen receptor [ER]/progesterone receptor [PR] < 10% HER2 negative [IHC 1+ or 2+ FISH non-amplified]) receiving any standard routine clinical NST regimen
  • Patient desires breast conserving therapy
  • Age 40 years or older; this age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of IBTR presumably due to underlying biologic differences
  • Female sex
  • If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer
  • Patient must have an initial nodal ultrasound that does not demonstrate more than four suspicious lymph nodes, any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present

Exclusion Criteria:

  • Radiologic evidence for a stage T3 or clinical stage T4 breast cancer
  • Clinical or pathologic evidence for distant metastases
  • Prior diagnosis of invasive or ductal carcinoma in situ breast cancer in the ipsilateral breast
  • Clinical evidence of progression of disease > 20% in the breast or new evidence of nodal metastases
  • Patient is known to be pregnant
  • Patient is participating in a NST protocol in which surgical excision of the breast and or lymph nodes are required

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945579


Contacts
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Contact: Henry Kuerer 713-745-5043 hkuerer@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Henry M. Kuerer    713-745-5043    hkuerer@mdanderson.org   
Principal Investigator: Henry M. Kuerer         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Henry Kuerer M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02945579     History of Changes
Other Study ID Numbers: 2016-0046
NCI-2016-01929 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0046 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Surveillance
Breast biopsy
Questionnaires
Surveys

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases